Cervico-vaginal radium applicator



R. G. FORDYCE CERvICO-VGINAL RADIUM APPLICATOR June 2, 1959 3Sheets-Sheet 1 Filed sept. s, 1954 Ran/uf 6 me m Wwf W mf A June 2, 1959R. G. FoRDYcE cERvIco-VAGINAL RADIUM APPLICATOR Filed Sept. 8, 1954 3Sheets-Sheet 2 INVENTOR. 6 far/yea ATTORNEYS June 2, 1959 R. FoRDYcEcERvIcowAGINAL RADIUM APPLICATOR 3 Sheets-Sheet Z5 Filed Sept. 8, 1954[NVE/v70@ Rufus G. Frcgyc'e United States Patent() CERVICO-VAGINALRADIUM APPLICATOR Rufus G. Fordyce, Glencoe, lll., assignor to RadiumService Corporation of America, Chicago, Ill., a corporation of DelawareApplication September 8, 1954, Serial No. 454,811

9 Claims. (Cl. 12S-1.2)

The present invention relates to a cervico-vaginal applicator, and moreparticularly to ,an applicator designed for the irradiation of thecerviX-uteri, the paracervical and parametrial tissues, and the vaginalvault.

One of the commonest sites of cancer in Women is the cerviX-uteri.Numerous modes of treatment by irradiation with radium have beendevised, but radium applicators of prior practices have proved to bediicult and painful to apply, and have generally failed to provide adesirable amount of homogeneous irradiation needed to objectively combatthe disease. Moreover, considering the drastic nature of the treatment,applicators of prior practices do not adequately protect the normaltissues from excessive irradiation.

It is a primary object of the present invention to provide acervico-vaginal applicator capable of more homogeneous irradiation inthe uterine cavity than was heretofore possible.

Another important object of the invention is to provide a cervical-uteriapplicator employing a pair of twin tandem intra-uterine stems ratherthan the single stem of applicators of prior practices.

A further object of the invention is to provide an applicator includinga plurality of radioactive material receiving arms or stems capable ofapplying a greater ratio of irradiation output to the paracervical and/or parametrial tissues.

Yet another object of the invention is to provide an applicator having apair of identical intra-uterine stems which may be positioned insubstantial abutting relationship for insertion into the uterine cervix,and which upon insertion separate from each other to accurately conformto the adjacent anatomy.

Still a further object of the invention is to provide an applicatorincluding a pair of vaginal arms which may be folded substantiallytogether for insertion into the vaginal cavity by a pair of forceps andwhich automatically separate into the desired treating position adjacentthe cervix upon Withdrawal of the forceps.

Still a further object of the invention is to provide an applicatorincluding a foldable pair of vaginal arms wherein a solid mass ofprotective metal is interposed between the radioactive sources in theapplicator and the portions of the adjacent anatomy which are notdiseased.

Another object of the invention is to provide an applicator including apair of intra-uterine stems and a pair of vaginal arms arranged anddisposed to collapse or fold into a relatively small bundle forinsertion into position by a forceps, and which, upon release of theforceps, automatically assume correct treatment positions with respectto the diseased tissues.

According to one form of the present invention, I provide a pair ofradioactive material receiving intra-uterine stems and a pair ofradioactive material receiving vaginal arms pivotally connected to acommon pivot pin, with the pair of stems disposed between or inwardly ofthe pair of arms. Resilient means urges the vaginal arms from acollapsed or folded position, wherein the outer ice ends of the arms arein contact with the respective stems, and the stems are disposed insubstantially parallel abutting positions, to a spread-apart positionwherein the.

arms diverge from said stems, and said stems diverge substantially fromeach other. The stems includev exterisions for cooperation with portionsof said arms at the inner ends thereof whereby the resilient force istransferred to the stems as the arms move outwardly of each:

v in the vaginal cavity, the stems are respectively engaged to bringthem into substantial abutting relationship whereby the stems may beinserted into the cervical os and thence into the cervical canal. Uponrelease of the.' forceps, the stems and arms are urged into a spread-.

apart position wherein the stems come into contact with the tissuesforming the cervical canal and the arms come into contact with thecervix. Preferably, one or.

both of the stem extensions includes an eye or hole t which a Withdrawalthread may be attached.

In another form of the invention the intra-uterine stemsare secured tothe upstanding ends of a helical spring wound around or received in saidcommon pivot pin, and said extensions are omitted. In this embodiment,the resilient bias placed on the intra-uterine stems isv completelyindependent of that placed on the vaginal arms, so that the stems willassume their body conforming conguration, once the applicator has beenapplied, independently of pathological or natural obstructionsinterfering with the desired positioning of the vaginal arms, and viceversa.

In yet another embodiment of the invention I employ the common pivot pinas a receptacle for radioactive material. This allows a radioactivesource to be placed immediately adjacent the cervical os, somethingwhich was not possible in applicators of prior practices.

It will be appreciated that the present invention provides substantialadvantages over applicators of prior practices. such that the applicatorautomatically conforms itself to the configuration of the anatomyadjacent which it is positioned and provides for a more effectiveirradiation of the diseased tissues. Moreover, the V or wedge shape thatthe stems assume with respect to each other serves Other objects andadvantages of the present inventionr will become apparent in thefollowing description of preferred embodiments of the applicator of thepresent invention, and the preferred use thereof.

Now, in order to acqaint those skilled in the art with the applicator ofthe present invention and with a preferred use thereof, I shalldescribe, in connection With the accompanying drawings, severalpreferred embodiments thereof.

In the drawings:

Figure l is a sectional view through the pertinentportion of the femaleanatomy showing a preferred form of the applicator in poistion duringtreatment;

Figure 2 is a sectional view through the applicator of Figure 1, lookingfrom the rear of Figure l, and is seen along the line 2-2 of Figure 3;

Figure 3 is a bottom view of the applicator shown in Figure 2, partiallyin section;

Figure 4 is a partially exploded perspective view of the applicator ofFigure 1; t

For instance, the mechanical construction is- Figure is a perspectiveview ofthe applicator of Figure 1 taken from another position, moreparticularly illustrating the novel common connecting and biasing means;

I Figure v6.is a; perspective viewv of the applicator of Figure lgripped by a suitable form offorceps for inserting'.l same;, Y I, l V YFigure 7 is a perspective view of another embodiment of applicator; l Y

Figure 8 is a sectionalview along line 8-8 of Figure 7;

Figure 9 is a perspective view of still another form of applicator,according tothe present invention; and

v.Figure l0 is av sectional view along line lil- 10 of Figure 9. 4 i

Referring now morefparticularly to Figure 1, reference numeral 10generally indicates a preferred form of the invention in positionfortreatment. Diagrammatically illustratedat 12 is the vaginal cavity, thefornices at 14, the cervix at 16 (shown largely replaced by cancertissue), thecervical canal at 18, and the body of the uterus at 20.

`The applicator 10 comprises generally a` pair of identical twin tandemintra-uterine stems 22 and a pair of identical vaginal arms 24. As shownin Figure 2, the stems 22 each compriseVv a plurality of hollowscrewthreaded segments or sections 26, 28, 30 and 32, with the segments32 merging into integral extensions 40. The segmentsY are adaptedtoreceive the radioactive material used in the treatment of thecervix-uteri, usually in the formofneedles containing radium. Theintegral extensions40 are formed with an inner loop 42 and outwardlyextending ends 44; the inner loops 42 receive the pin 48 having aninternally screw-threaded hole at one end thereof toreceive the screw 50(see Figures 2, 4 and 5 for the best illustrationy of thisstructur'e).Outwardly extendingv ends; 44may bepierced at, 45 for insertion of awithdrawal thread, as will hereinafter be made clear. The vaginalY arms24ceach are formed out of solid blocks of a suitable metal and comprisegenerally uniform necks 52 having ovoid shapedends 54. Each of the arms24 is formed with aplurality ofspaced-'apartcompartments 56 adapted toVreceive the radioactive material employed to; treat the cervixlandvaginal fornices. Each arm 24 includes `a solid plate or cap 58 held Vinplace by countersunkscrews 60 passing through suitable holes 62 in Vthec'aps 'and into screw-threaded holes 64 in the arms. The arms 24 areVfurther formed withpierced lugs or loops 66 andt66a, respectively (seeFigure 5'), adapted to receive the pin 48, and positioned between therespective loops fare aA pair of lspringsg69 whichV urge the arms 24outwardly of`each other. The arms areformed with engaging surfaces orabutments 70 onthebottoms thereof which contact each other 'as shown inFigure 3 to preclude further movement of the arms 24 with respect toeach other. Each engaging surface or abutment Vis slotted at 72 as shownin Figures V-3 and 5 to receive an extension 40 of stems 22. It willbeappreciated that kas the Yarms 24 move outwardly of each other under theAaction of the springs 68, the surfaces or abutments 70 will engage therespective extensions 40 to pivot the stems about pin 48 to separate thestems from each other. The undersurfaces of the arms 24 are notched *orrecessed as at 74 to receive the working ends of a forceps generallyindicated at 76 in Figure 6.

In use, the stems 22 and the arms 24 are supplied with the requisiteamount of radioactive material needed to treat a particular patient, andthe applicator is gripped by the forceps 76. It will be noted that theapplicator is then in its collapsed or folded position wherein the stems22 are in substantially parallel abutting relationship, and thetarms 24engagevtherespective stems` 24. The applicator is then insertedA throughthe vaginal cavity, with the intra-uterine stems 22 being passed throughthe cervical os into the'cervical canal, The forceps 76 is thenwithdrawn, and the springs 68 urge the stems 22 and the arms 24 :to thespread-out position substantially as shown in Figure 1, depending, ofcourse, onsthefspacing of the anatomicalY structures due to natural orpathological causes. Before insertion, a withdrawal thread 78 is passedthrough the holes 45 to aid in withdrawing of the applicator after theperiod of treatment has expired.

It will be appreciated that the twin stems 22, upon release of theforceps, will engage. the two sides of the cervical canal and providetwo radioactive sources in this area. Each half of the cervical canal isthus effectively and homogeneously exposed to radiation. The arms 24will automatically come into close contact with the outer surface of thecervix and the vaginal fornices under the action of the springs 68; theupper surfaces of the arms 24 as shown in Figure l generallyapproximates the normal configuration of the cervix. The shape of thearms 24 is particularly helpful in insuring that the fornices willreceive proper treatment, as will be immediately obvious from Figure l.

In the illustrated embodiment, the fixed spread at the tips of the stemsis preferably approximately three centimeters, taperingconvergently,approximately to contact at the cervical os whenvtheapplicator isl in treatment posi-` tion. The applicator thus conformssubstantially in outline to the lateral walls of the uterine cavity. Asthe sources of radioactivityl in the stems and in the arms -24 arerelatively close together, a greater ratio of the irradiation outputthan was possible in prior applicators is delivered to the parac'eivicalarea. This is because the radioactive material containing portion ofeach stem 22 is necessarily closerrto the radioactive materialcontaining portions of the arm 24 immediately adjacent it than, forinstance, the radioactive source of a single stem of applicators ofprior practices could be to the radioactive sources of either arm.Moreover, the distance between the radioactive sources in the stems 22and the arms 2'4, that is the interior of stems 22 and vthe compartments56, is fixed once thearms 24 have been released by the forceps, whetheror not therstems 24` failto separate from each other or moveoutwardly ofeach other the Vfull three centimeters referred to above. This isbecause the movement of the arms 24 outwardly of each other, after thearms 24 are released from the forceps, is controlled vby and isdependent upon movement of the -extensions 40 (up to the point where theabutments 70 engage eachother) since arms 24 bear against saidextensions under the action of springs 68, Therefore, as the stems 22separate on withdrawal of forceps 76, the arms 24 separate the sameamount; in effect the stem and arm of each side of the applicator movetogether as the stems separate.

For example, when the applicator 10 is positioned as shown in Figure lwith the stems -22 together as shown in Figure 6, but with the arms -24released to move as far as they can with respect to each other and with`respect to the-,stems 22, there will be a space between the abutments 70when the arms 24 have moved as f ar apart as possible under the tensionof the springs without causing separation of the stems; this is becausethe extensions 40 hold the abut-ments 70 away from each other, theextensions 40 as shown in Figure 3 then being aligned in the verticalaxis of the gure. As the stems 22 separate under the action ofthesprings through the arms 24 the abutments 70 move toward each other andthe extensions 40 move into the respective slots 72. The movement of thearms 24 with respect to each other fis therefore controlled by thespacing between stems 22 and the distance between the respective arms 24and stems 22 is fixed regardless of the gap or spacing between the stems22.

Another feature of the applicator which is of importance is that the Vor wedge shape of the twin fstems 422,

when allowed to separate, serves to resist expulsion fofv the stems fromthe uterus, and also serves to anchor the vaginal arms 24 in and againstthe fornices. 'As the applicator is withdrawn by use ofthe thread 78,the ends 44 will Vbe urged together, thereby urging the stems 22together 'against the action of the. springs 68 to allow` vradioactivityby bulky `gauze packing. l v l applicator, the Vaginal arms areessentially solid blocks Smooth Withdrawal Ot the Stems from. the cervixwith a of patient discomfort. The stems `22 are of a reduced diameter at80 (see Figure 2), the portion thereof adjacent the cervical os, tominimize dilation and the possibility of tissue injury.

A further improved feature of the applicator is the construction of thevaginal arms 24. In conventional applicators the vaginal arms haveconsisted of relatively thin walled capsules arranged in parallel withuniform open places separating the capsules or with a single largecapsule of ovoid shape at the outer extremity of each arm. In the past,irradiation protection of adjacent normal structures has been dependentupon separating these normal anatomical structures from the sources ofIn the present of metal, and the radioactive sources are housedin thecompartment or compartments adjacent the affected tissues. Thus, theradioactive material may be placed in the compartments which will bepositioned closely adjacent the affected tissues, and the normal tissuesspaced from these compartments will be -separated from the radioactivematerial by the solid mass of metal interposed between them and thefilled or partially filled compartments.

The applicator is designed for use of the accepted standards ofradioactive sources with the conventional 0.5 millimeter of platinum(beta ray) ltration, and for the variable placement of such sources insingle, tandem or team arrangement for general or localized irradiation.The applicator therefore is readily adapted for use in practicing eitherthe ovoid or multiple source techniques now commonly employed intreatment for cancer of the cervix. Thus, the compartments 56 at theends of arms 24 may alone be used in practicing the ovoid technique, orall compartments 56 may be employed in practicing the multiple sourcetechnique. The sections 28, 30 and 32 forming the twin stems 22 arepreferably of a length suflicient to house the standard length of radiumneedle (2O millimeters) and preferably the stems 22 are suiciently longto extend to the fundus of the cervical canal. The stems 22 may be madeup of more or less sections or segments than illustrated to `adapt theapplicator to a particular patients needs.

The mechanical construction of the applicator is such that locking ofthe intra-uterine stems 22 or the vaginal arms 25 in either the open orclosed position is impossible, and the applicator as a unit is smoothand rounded in shape and contour conforming substantially to the normalanatomy for patient comfort. The construction of the applicator alsosimpliiies the readying of the applicator for use and the operativeprocedures for insertion and reduces irradiation exposure. Assembly anddisassembly of the applicator involves only the removal of the pin 48,and the compartments containing the radioactive substances are closedIby a solid face plate or cap 58 rather than a separate cap for eachradioactive material container, as has been the case in applicators ofprior practices.

Figures 7 and 8 illustrate a modied form'of applicator 81 wherein theaction of the intraduterine stems and the vaginal anms is independent ofeach other, and a source of radioactivity is disposed immediatelyadjacent the cervical os. The modified form of applicator includes thetwin tandem intra-uterine stems 22 and the modified vaginal arms 82. Asshown more particularly in Figure 8, the common pivotal pin comprises anelongate tube 84 having an enlarged head 86 at one end thereof and whichis internally screw-threaded at the other end thereof to receive thescrew 88. The tube 84 is sufficiently large so that a source ofradioactivity, such as a radium needle, may be disposed therein. Thepierced lugs or loops 90 and 92 of the respective vaginal arms 82receive the tube 84 to pivotally mount the vaginal arms on the tube.Also received on the tube 84 are a .pair of spacedsleeves 94 aud 96carrying helical springs' 98 and 100, respectively, and the helicalspring 102. The springs 98 and 100 act to bias the `arms 84 away fromeach other in the same manner described in connection with thevaginalarms 24 of Figures l to 6, and the-sleeves 94 and 96 position thespring 102 at the center of the tube 84. In this embodiment, theintra-uterine stems are mounted on the upstanding ends 101 of thehelical spring 102, as shown more particularly in Figure 8. 4 Thevaginal arms 82 carry at the ends thereof receptacles 104 in whichsources of radioactivity may be disposed as required. The undersurfacesof the arm 82 are notched or recessed similar to the recesses 74illustrated in Figure 5 so that the applicator may be grasped by aforceps similar to that shown in Figure 6.

The applicator 81 of Figures 7 and 8 is inserted in the same lmanner asapplicator 10. Upon release, however, the vaginal arms 82 and the stems22 act inde.- pendently of each other in conforming to the outline ofthe anatomy adjacent to which they are disposed, so that if pathologicalor normal body structures interfere with the normal positioning of, forinstance, the arms 82, the stems 22 will still separate to conform tothe outline of the cervical canal, and vice versa. Also, in cases wherea recess or cavity has for-med in the wall of the anatomy defining thecervical canal, and one of the stems is disposed adjacent the recess orcavity, Vthe helical spring will urge sai-d stern within the recess orcavity independently of the positioning of the vaginal arms S2. Awithdrawal thread, -if so desired, may be attached in any suitablemanner to aid in withdrawing the applicator from the vaginal canal.

Figures 9 and l0 illustrate a further-form of applicator wherein thestems 22, arms 24, common pivot pin 4 8 with screw 50, and springs 68 ofFigures l to 6 are employed. In this embodiment, however, a helicalspring 106, similar to spring 102 of Figures 7 and 8, is received on thepin 4 8, and the stems 22 are mounted on the upstanding ends 108thereof. It will be appreciated that this embodiment functions similarlyto -that of Figures 7 and 8, employing, however, the multiple sourcearms 24 of Figures l to 6.

I comprehend that the Various elements illustrated and described inconnection with the three disclosed embodiments of the invention may beinterchanged with slight modification, if necessary, of the otherelements making up the particular embodiment. For instance, the hollowradioactive material receiving tube 84 of Figures 7 and 8 could be usedin connection with the embodiments illustrated in Figures l to 6 andFigures 9 and l0. Moreover, the movement of the stems 22 of theembodiments of Figures 7 to 10 may be controlled by the movement of thevaginal arms in the manner described in connection with the embodimentshown in Figures l to 6.

They various described embodiments may be made from any suitable metals,such as brass, stainless steel, Monel metal, copper, or the like.

The foregoing description and the drawings are given merely to explainand illustrate my invention, and the invention is not to be limitedthereto, except .insofar as the appended claims are so limited sincethose skilled yin the art who have my disclosure before them will beable to make modifications and 'variations therein withoutdeparting fromthescope of the invention.

I claim:

l. A cervico-vaginal radium applicator comprising, a pair ofintra-uterine stems pivotally connected together adjacent a like end ofeach for movement between a contracted position wherein they are insubstantially side-byside and aligned relation and a spaced apartposition wherein they are in spread apart substantially V-shapedrelation, a pair of vaginal arms pivotally connected together adjacent alike end of each and positioned on either side of said stems, said armsbeing pivotally connected for movement between a contracted positionwherein the 'asesora' free ends of said arms respectively abut saidstems and a spaced apart position wherein said free ends are both spacedfrom the said stems, with the pivotal connection of said arms beingpositioned adjacent the pivotal connection of said stems, and means forbiasing said stems and said arms to their respective spaced apartpositions, said arms each being formed with radium receivingcompartments and said stems comprising radium receiving compartments,whereby, said stems and said arms when clamped in said contractedpositions may be inserted through the vaginal cavity and said stemspassed through the cervical os into the cervical canal, and whenunclamped, said means urges said stems and said arms into said spacedapart positions wherein said stems engage opposite sides of the cervicalcanal and said arms engage the outer surface of the cervix.

2. A cervico-Vaginal radium applicator, comprising a pair ofintra-uterine stems pivotally connected together adjacent a like end ofeach for movement between a contracted position wherein they are insubstantially sidelay-side and aligned relation and a spaced apartposition wherein they are in spread apart substantially V-shapedrelation, a pair of vaginal arms pivotally connected together adjacent alike end of each and positioned on either side of said stems, said armsbeing pivotally connected for movement between a contracted positionwherein the free ends of said arms respectively abut said stems and aspaced apart position wherein said free ends of said arms are bothspaced from said stems, common pin means effecting said pivotalconnections of said stems and said arms, and spring means for biasingsaid stems and said arms to their respective spaced apart positions,said arms each being formed with radium receiving compartments and saidstems comprising -radium receiving compartments, whereby, said stems andsaid arms when clamped in said contracted positions may be insertedythrough the vaginal cavity and said stems passed through the cervicalos into the cervical canal, and when unclamped, said spring means urgessaid stems and said arms into said spaced apart positions wherein saidstems engage opposite sides of the cervical canal and said arms engagethe outer surface of the cervix.

3. The applicator set forth in claim 1 wherein said spring meanscomprises spring means acting only on said vaginal arms, said like endsof said stems including exten- ,sions for cooperating with said likeends of said arms to urge said stems into said spaced apart position.

4. The applicator set forth in claim l wherein said lspring meanscomprises separate spring means acting on Vsaid arms and said stems,respectively.

lare in substantially side-by-side and aligned relation and 'a spacedlapart position wherein they are in spread apart substantially V-shapedrelation, pin means etecting said pivotal connection between said stems,spring means for biasing said stems to their respective spaced apartpositions, saidV stems comprising radium receiving compartments, andradium receiving compartment means secured to said pin means, saidcompartment means being larger than the cross sectional dimension ofsaid stems when in said contracted position, whereby, said stems whenclamped in said contracted position may be inserted through the vaginalcavity and passed through the cervical os into the cervical canal, andwhen unclamped, said spring means urges said stems into said spacedapart position wherein said stems engage opposite sides of the cervicalcanal and draw said radium receiving compartment means against thecervix.

8. A cervico-vaginal applicator comprising a pair of vaginal armspivotally connected together adjacent a like end of each, pin meanseiecting said pivotal connection of said arms, said arms being pivotallyconnected for movement between a contracted position wherein the freeends of said arms are positioned adjacent each other and a spread apartposition wherein said free ends of said arms extend away from eachother, said arms each being formed out of a solid length of metal andeach length of metal being formed with a plurality of radium receivingcompartments that extend parallel to said pin means, said lengths ofmetal being, transversely of the axis of said piu means and between saidlike ends and said free ends of the respective arms, of a thickness`greater than the transverse dimension of said compartments, andintra-uterine stem means secured to said pin means, whereby, said arms,when clamped in said contracted position, and said stem means may beinserted through the vaginal cavity and said stem means passed throughthe cervical os into the cervical canal, and when said arms arereleased, said spring means urges said arms into said spaced apartposition wherein said arms engage the outer surface of the cervix.

9. The applicator set forth in claim 8 wherein said compartments eachinclude an open end and a closed end, said open ends of saidcompartments all being formed in the same side of the respective arms,and including a single cover plate for each arm that is proportioned toclose the open ends of all compartments in the arm, and means forsecuring said cover plates to the respective arms.

References Cited in the tile of this patent UNITED STATES PATENTS 12,965Rosenthal May 29, 1855 305,171 Garson Sept. 16, 1884 662,716 GacdekeNov. 27, 1900 1,543,859 Leman June 30, 1925 1,628,133 Ferst May 10, 19272,516,261 Schutt July 25, 1950 FOREIGN PATENTS 699,329 Germany Nov. 27,1940 852,277 Germany Oct. 13, 1952 OTHER REFERENCES Uterine RadiumApplicator, American Journal of Surgery, vol. VIII, No. 4, April, 1930,pp. 862-5.

